Impurities, Degradants and Potential Genotoxic Impurities: Control of Drug-related Impurities in Pha

Venue: Holiday Inn Somerset

Location: Somerset, New Jersey, United States

Event Date/Time: Mar 14, 2013 End Date/Time: Mar 14, 2013
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Description

This course is designed to provide participants with an understanding of the regulatory expectations for impurities, degradants and potential genotoxic impurities in drug substances and drug products, including predicting and characterizing these impurities, how to establish specifications and to discuss practical strategies for reporting results and addressing situations where the limits are exceeded. There will be ample opportunity to discuss questions and challenges from the participants.

Upon completion of this course the learner should be able to:

  • Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
  • Implement a testing program to appropriately characterize these impurities, utilizing strategies to minimize resource expenditures
  • Develop specifications which will conform to regulatory expectations
  • Develop an process for reporting impurities and addressing OOS situations

Venue

195 Davidson Ave
Somerset
New Jersey
United States
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